Clinical Trials

Current Resources, Networks and Clinical Trials include:

1. Drug Induced Liver Injury Network (DILIN)

There is a critical need to develop a means of predicting, detecting and diagnosing drug (or herbal product)-induced liver injury (DILI) in the United States. In 2004, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) established the Drug-Induced Liver Injury Network (DILIN) to conduct clinical and basic science studies of DILI. UNC was one of the charter members of the Network. Dr. Paul Watkins, Professor of Medicine and Toxicology at UNC and the Hamner Institutes for Health Sciences, chairs the DILIN Steering Committee. DILIN now has 8 centers nationwide and has three major study components. Click Here For More Information About DILIN

2. Hepatitis B Research Network (http://www.hepbnet.org)

The Hepatitis B Research Network brings together clinical centers with expertise in caring for patients with chronic hepatitis B virus (HBV) infection. An estimated 2 billion people worldwide have been infected with HBV and about 400 million persons are living with chronic HBV infection. National surveys indicate that 0.3% to 0.5% of U.S. residents have chronic HBV infection, and 47% to 70% of these persons were born outside the United States. The goal of the Network is to conduct research on chronic hepatitis B, in order to better understand the physiological effects of the disease and develop effective treatment strategies with the currently available therapies.

3. Transplant Outcomes Data Consortium (TDOC)

The TDOC is a seven center consortium that will consolidate clinical data related to pre and post liver transplant patients.

4. SyNCH

A Multicenter, Randomized, Double Masked, Placebo Controlled Phase II Study to Assess the Safety and Efficacy of a Standardized Orally Administered Sillymarin Preparation (Legalon®) for the Treatment of Non-Cirrhotic Patients with Non-Alcoholic Steatohepatitis

5. SyNCH

A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase II Study to Assess the Safety and Efficacy of a Standardized Orally Administered Silymarin Preparation (Legalon) for the Treatment of Patients with Chronic Hepatitis C who Failed Conventional Antiviral Therapy.

6. CTRC-2779

Steady-State Pharmacokinetic Interactions of Green Tea Catehins and Silymarin Flavonolignans in Treatment Naive Patients with Chronic Hepatitis C Infection This is a five week study investigating the effects of silymarin, also known as Milk Thistle, and Green Tea in patients with hepatitis C. These two herbal products have been used by patients in the past because they are thought to have liver protecting effects, but this benefit has not sibeen proven. The purpose of this study is to learn if the combination of Milk Thistle and Green Tea can achieve higher levels in the body and have greater antioxidant effects than if given alone.

7. Abbott M11-602

Abbott M11-602 is investigating the efficacy and safety of direct acting antiviral agents with standard of care in naive subjects.

8. The EXTEND study

The EXTEND study is a 3-year virology follow-up study in subjects previously treated with telaprevir in select clinical studies.

9. The CRISP study

The CRISP study is an exploratory study investigating the activity of Interferon Stimulated Genes through intracellular phosphoprotein profiling in patients who have already been treated for hepatitis C.

10. DNA Bank

The staff of the Liver Program maintains a genomic DNA bank of samples collected in an ongoing antiviral protocol for hepatitis C. This bank is part of a collaboration with the Translational and Clincal Sciences Institute.

11. Sample Bank

Under an IRB-approved protocol, serum and tissue samples are collected from patients who consent during clinic visits with the Liver Program. This bank includes serial samples before, during and after antiviral therapy, as well as from pre and post transplant patients.

Environment

University of North Carolina at Chapel Hill

The environment at UNC-Chapel Hill provides a rich resource that encourages and supports programs like the Liver Program. In addition, the close proximity of the Schools of Allied Health (Medicine, Dentistry, Nursing, Pharmacy and Public Health) provides the opportunity for close collaboration and multidisciplinary research efforts.

UNC is currently has $264.3 million in NIH funding which places us in thirteenth place among research institutions. This number has grown steadily over the last 10 years. There is also a strong training mission as the university now ranks seventh in federal support for fellowships, traineeships, and training grants.

When evaluating level of private support, faculty, advanced training and research, UNC-Chapel Hill was ranked fifth among public universities in a report titled “The Top American Research Universities” completed in 2002. UNC investigators have also been successful in licensing and patenting, ranking 12th among research universities based on a review for 2002.

School of Medicine

The School of Medicine is comprised of 27 departments and 31 centers. The Liver Program is placed within the Department of Medicine which offers many resources for clinical needs, faculty development and research infrastructure. In the year 2001, faculty brought in $54.5 million of NIH funding and this ranks the UNC Department of Medicine 11th out of 111 departments of medicine nationwide.

The North Carolina Translational and Clinical Sciences Institute (NC TraCS Institute)